(85 days)
No
The description focuses on the material properties and physical function of a root canal sealer, with no mention of AI or ML.
No
The device is a root canal sealer, which is a material used to fill root canals, not a therapeutic device designed for treatment or therapy.
No
The device is a root canal sealer, used for filling the canal system, not for diagnosing a condition.
No
The device description clearly states it is a mineral trioxide aggregate (MTA) and resin root canal sealer, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "permanent scaling of root canals" and "may be used in combination with root canal obturation materials." This describes a therapeutic or restorative procedure performed directly on the patient's anatomy (root canals).
- Device Description: The description details a material used to fill the root canal system during endodontic treatment. This is a material applied in vivo (within the living body).
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens outside the body.
Therefore, MTA-Fillapex is a medical device used in a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
MTA Fillapex is a mineral trioxide aggregate (MTA) and resin toot canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA-FILLAPEX is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MTA Fillapex has undergone the following testing:
- Working time
- Setting time
- Flow
- Radiopacity
- Solubility
- Flow/Viscosity
- Free lime content
These tests have shown that MTA Fillapex and K113568 are substantially equivalent to the new MTA Fillapex. Both devices have comparable flowability, working times, setting times, dimensional change following setting, solubility, shelf life and biocompatibility properties.
Since MTA Fillapex's chemical composition is based on the principal chemical components in K113568, the biocompatibility test provides evidence that the product is non-mutenagenic, does not cause an allergenic potential after multiple uses and has a good tolerance. The shelf life, bench and biocompatibility testing, provide evidence that the chemical and physical properties are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K113568 MTA Fillapex by Angelus, K010940 Sealapex by Sybron
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
140247
APR 2 5 2014
Image /page/0/Picture/2 description: The image contains the logo for Angelus Science and Technology. The logo features a stylized letter 'A' inside of a circle on the left. To the right of the circle is the word 'angelus' in lowercase letters, and below that is the phrase 'science and technology' in smaller letters.
510(k) Summary
| Proprietary Name | MTA Fillapex |
|---|---|
| K Number | K140247 |
| Date Prepared | April 25, 2014 |
| Submitter | Angelus Industria de Productos Odontologicos |
| Waldir Landgraf, 101 | |
| Londrina, Brazil 86031-3200 | |
| Telephone: | +55 43 2101 3200 |
| Official Contact | Tara Conrad |
| TechLink International Consulting | |
| 18851 NE 29th Avenue Suite 720 | |
| Aventura, FL 33180 | |
| TEL- (305) 377-0077 | |
| Common Name: | Resin, Root Canal Filling |
| Trade Name: | MTA Fillapex |
| Classification: | Class II |
| Product Code: | KIF |
| Classification Panel: | Dental |
| Regulation Numbers: | 21 CFR 872.3820 |
| Substantial Equivalence: | K113568 MTA Fillapex by Angelus |
| K010940 Sealapex by Sybron |
Description of Proposed Device
MTA Fillapex is a mineral trioxide aggregate (MTA) and resin toot canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA-FILLAPEX is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation.
Indications for Use
MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.
1
Image /page/1/Picture/0 description: The image shows the logo for Angelus Science and Technology. The logo features a stylized "A" inside of a black circle on the left. To the right of the circle is the word "angelus" in lowercase letters. Below the word "angelus" is the phrase "science and technology" in a smaller font.
Device Comparison Table
| Subject Device | Predicate Device | ||
|---|---|---|---|
| MTA Fillapex by Angelus | K113568 MTA Fillapex by | K010940 Sealapex by | |
| K140247 | Angelus | Sybron | |
| Indications for use | MTA-Fillapex is a root canal | ||
| sealer intended for the | |||
| permanent scaling of root | |||
| canals and may be used in | |||
| combination with root canal | |||
| obturation materials. | MTA-Fillapex is a root canal | ||
| sealer intended for the | |||
| permanent scaling of root | |||
| canals and may be used in | |||
| combination with root canal | |||
| obturation materials. | Sealapex 4 is a | ||
| calcuium hydroxide, | |||
| polymeric resin, root | |||
| canal filling material | |||
| that is used in | |||
| conjunction with gutta | |||
| percha or silver | |||
| endodontic points. | |||
| Design | Two paste system | ||
| (base/catalyst) | Two paste system | ||
| (base/catalyst) | Two paste system | ||
| (base/catalyst) | |||
| Flow | 33.38 mm | 27.66mm | 25.15 (±1.73) mm (1) |
| Material components | Dicalcium and | ||
| tricalcium silicate, | |||
| tricalcium aluminate, | |||
| calcium oxide, | |||
| pentaerythritol | |||
| rosinate, n-ethyl-o, | |||
| p-toluenesulfonamide | |||
| salicylate resin, | |||
| bismuth oxide, fumed | |||
| silica, titanium dioxide | Dicalcium and | ||
| tricalcium silicate, | |||
| tricalcium aluminate, | |||
| calcium oxide, | |||
| pentaerythritol | |||
| rosinate, n-ethyl-o, | |||
| p-toluenesulfonamide | |||
| salicylate resin, | |||
| bismuth oxide, fumed | |||
| silica, titanium dioxide | Titanium Dioxide, | ||
| Fumed Silica, Bismuth | |||
| Trioxide, Isobutyl | |||
| salicylate resin, N - | |||
| ethyl toluene | |||
| solfanamide resin, | |||
| Calcium Oxide, Zinc | |||
| Dioxide | |||
| Working time | 23 minutes | 35 minutes | Minimum 120 minutes |
| Setting time | Minimum 130 minutes | Minimum 130 minutes | 45 minutes after |
| placement | |||
| Solubility | 2.47% | 0.1% | >4% (2) |
| Shelf Life | 2 years | 2 years | 2 years |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Standards | ISO 6876:2012 | ISO 6876: 2001 | ISO 6876: 2001 |
Substantial Equivalence
The subject device and the predicate devices have intended use and have the same technological characteristics, including the same range of physical and chemical properties. The subject and predicate devices are packaged in similar materials and utilize similar methods of application. Any differences in the technological characteristics do not raise new issues of safety or efficacy.
Performance Data
MTA Fillapex is a modification of K113568. They are designated for the equivalent dental applications and have comparable chemical and physical properties, and performance specifications. An additional predicate device (K010940) includes each specific chemical component that is equivalent to those found in MTA Fillapex, providing evidence that these materials are safe and effective for medical device use. Furthermore, MTA Fillapex and K113568 have equivalent packaging containers and delivery systems.
MTA Fillapex has undergone the following testing:
2
Image /page/2/Picture/0 description: The image shows the logo for Angelus Science and Technology. The logo consists of a black circle with a white "A" inside, followed by the word "angelus" in a sans-serif font. Below the word "angelus" is the phrase "science and technology" in a smaller font.
These tests have shown that MTA Fillapex and K113568 are substantially equivalent to the new MTA Fillapex. Both devices have comparable flowability, working times, setting times, dimensional change following setting, solubility, shelf life and biocompatibility properties.
Since MTA Fillapex's chemical composition is based on the principal chemical components in K113568, the biocompatibility test provides evidence that the product is non-mutenagenic, does not cause an allergenic potential after multiple uses and has a good tolerance. The shelf life, bench and biocompatibility testing, provide evidence that the chemical and physical properties are substantially equivalent.
Design Control Activities
The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA) The design verification tests that were performed as a result of the risk analysis assessment are listed in the table below:
| Modification | Test Performed | Acceptance criteria |
|---|---|---|
| Titanium dioxide was | ||
| added to the base paste | 1. Working time |
- Setting time
- Flow
- Radiopacity
- Solubility | 1. 23 minutes
- 130 minutes
- Minimum of 20 mm
- Minimum of 3 mm
- Maximum 3% |
| | Internal Tests | |
| | 1. Flow/Viscosity | 1. Base Paste 20-22
mm / Catalyst Paste
27-29 mm
Mixed pastes after
30 min 21-23 mm |
| | 2. Radiopacity | 2. Greater than 3mm
of the aluminium
scale |
| | 3. Setting time | 3. 130 minutes |
| | 4. Free lime content | 4. 3-5% |
The test methods are the same as those submitted in the original submission.
3
Image /page/3/Picture/0 description: The image shows the logo for Angelus. The logo consists of a circular icon with a stylized "A" inside, followed by the word "angelus" in a bold, sans-serif font. Below the word "angelus" are the words "science and technology" in a smaller, lighter font.
Conclusion
MTA Fillapex has the equivalent indications for use, comparable chemical compositions, physical properties and performance specifications to K113568. The additional chemical component found in MTA Fillapex were found to be as safe and effective as the predicate.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, M1) 20993-0002
April 25, 2014
Angelus Industria de Productos Odontologicos C/O Tara Conrad TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180
Re: K140247
:
Trade/Device Name: MTA Fillapex Regulation Number: 21 CFR 872.3820 Regulation Name: Resin, Root Canal Filling Regulatory Class: II Product Code: KIF Dated: March 14, 2014 Received: April 4, 2014
Dear Ms. Conrad:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Conrad
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Susan Rinno, DDS, MA
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
Device Name: MTA Fillapex
510(k) Number: K140247
Indications for Use:
MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 801 Subpart C) .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
AND/OR
oncurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Sheena A. Green -S 2014.04.25 12:35:13 -04'00'
Page 12 of 131 Special 510(k) MTA Fillapex